SpaceFile®

Basic Information

• Brand Name: SpaceFile®
• Primary DI: D746400341
• Version / Model: 40034
• Catalog Number: 40034
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 9
• Record Status: Published
• Publish Date: 2021-12-16
• Public Version: 7
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 305b3073-ddb8-4604-a334-fce73bad0a25

Device Description

SpaceFile®IPR Strips-Double Sided Assorted Pk 9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHM	Strip, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44730	Interproximal reduction kit	A collection of devices intended to be used for interproximal reduction (IPR), which is the reduction of contact between adjacent teeth during orthodontic alignment of the teeth. Fine abrasives are typically used to minimize pressure and allow the formation of spaces between the teeth, enabling more effective therapy without excessive interproximal contact, which may prolong or complicate teeth alignment. The device may include burs, abrasive disks, abrasive strips, thickness gauges and charts for tracking of reproximation. This device is reusable, but certain items will need to be replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D746400340	HIBCC
Primary	D746400341	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]